Team Horizon is seeking a Validation Engineer for our clients Technical Operations team in the Northwest. This is a fixed term contract for 12 months and will report to the Validation Team Lead. Why you should apply: This role will provide you the opportunity to get exposure to a broad range of validation activities on site, and you You will be responsible for co-ordinating the development and maintenance of the companys validation program in compliance with all applicable regulatory and company requirements. What you will be doing: Co-ordinate, implement and participate in the site Validation Program. Ensure all computerised systems are qualified in compliance with Data Integrity policies and regulatory requirements. Co-ordinate / direction and participate in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards. Generate/maintain Validation Master Plans. Generate /maintain Project Validation Plans. Generate validation plans, write protocols and final reports to cGMP standard. Review / approve of protocols and final reports as required. Manage validation change control process. Adhere to and support all EHS & E standards, procedures and policies. What you need to apply: 3rd level qualification in a relevant engineering or scientific discipline. A minimum of 2 years experience in a cGMP regulated pharmaceutical manufacturing environment. High level of attention to detail and mental concentration, to ensure accuracy and compliance. Excellent communications skills with the ability to write protocols and reports. Proven problem-solving skills and the ability to adapt to new regulatory requirements. Benefits: pension Healthcare TPBN1_IJ
Reliability Engineer Team Horizon is seeking a Reliability Engineer for a client in Mayo who will be supporting the Maintenance Excellence Program (MEP) through advanced reliability engineering methods. Why you should apply: This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses. There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve peoples lives. Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally. What you will be doing: Develop a reliability road map for own business unit and receive endorsement from the Senior Leadership Team. Drive reliability culture by leading Reliability Centred Maintenance, Root Cause Analysis, Preventive Maintenance Optimisation and Reliability Improvement Project initiatives. Evaluate and expand the predictive maintenance program to identify and prevent emerging failures and maintain a rolling yearly log of cost savings. Analyse highly automated machinery to generate a top 10 bad actor profile and identify, execute and report on actions taken for the top 3 high value detractors. Link actions to financial benefit and align priorities with the largest opportunities for the business. Build strong relationships with Global Engineering and local engineering and maintenance teams. Be a key contributor in the reliability engineering community of practice and smart maintenance initiatives. Ensure compliance with policies, procedures and regulatory standards. Champion good EHS practices and support the site safety culture What you need to apply: Third-level qualification in Engineering. 3+ years experience within a regulated and/or highly automated environment. Strong data analytics skills. Reliability engineering and continuous improvement experience and/or certification desirable. (Green belt and/or CMRP or CRL preferred). Demonstrated ability to analyse machinery, conceptualise, implement and quantify significant improvements in OEE. Skills: Reliability Reliability Centered Maintenance Root Cause Analysis Continuous Improvement Benefits: healthcare pension bonus Parking TPBN1_IJ
Team Horizon is seeking a Senior Quality Specialist on an initial 12-month contract. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. This will involve partnering with major stakeholders such as Manufacturing, QC, QPs, Technical services, Engineering and Planning to optimize patient supply. Why you should apply: Join a team who unleash bold thinking with the power to inspire life‑changing medicines. Hybrid role with a mix of in-person working to give a platform to connect, work at pace and challenge perceptions with balance of remote working 2 days per week. What you will be doing: Quality Oversight for new product introduction in Bulk Drug Substance facility. Quality oversight for new or modified facilities, equipment, technologies, including analytical, as well as other continuous improvements and requalification’s. Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating manufacturing Review and Approve project documents involving cross‑functional, multi‑departmental teams including: Operations, Process Engineering, Quality Control, Quality Assurance, Facilities, Equipment and others. Review and approval of qualification/verification/validation documents for facilities, equipment, processes, analytical methods, suppliers, software and others. (e.g. URS, Facility, Utility, IT Systems, Test Methods, and Equipment validations) to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures. Quality oversight on operations and technical services to review and approve Process descriptions , sampling plans, operational procedures, process validation and cleaning validation documents Review and Approve TRA’s, MSRs, SAP requests related to new products . Provide QA support for supplier qualifications. QA review all analytical facility, equipment and method qualifications and validations. Ensure all Materials are sampled and released as per the approved specifications and procedures . Investigation and approval of deviations generated encountered during qualification/validation testing. Participation in the project change control program and deviations for modifications to new and existing systems. equipment. Provide guidance to project teams on Quality regulations for Validation strategy and approach. Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Commercial Operations groups. Provide sound QA and Compliance support to manufacturing, engineering, automation, utilities, supply chain, and material movement and laboratories. Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives. Actively support audit readiness activities and regulatory agency and internal audits. What you need to apply: Third level qualification e.g. B.Sc. in science/pharmacy or equivalent with a minimum of 6-8 years’ experience in cGMP Quality environment Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable. Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing. Excellent accuracy and attention to detail Good knowledge of relevant computer packages e.g. Delta-V, Veeva vault or similar Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities. High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Previous QA experience aligned to Technical Services, Engineering/CQV reviews, operational (batch records, procedures), supplier qualification, packaging lines, warehousing (including temperature mapping of, along with fridges and freezers) and QC analytical qualifications/validations and laboratories of particular interest. Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written #J-18808-Ljbffr
Team Horizon is seeking a Senior Product QA Manager & QP to join our clients team. This is a leadership role and is responsible for compliance with marketing authorisations, current Good Manufacturing Practices (GMP), and supporting New Product Introductions (NPIs). Why you should apply: This is an excellent opportunity to make an impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience. What you will be doing: Manage QP , Regulatory, Change Management and New Product Introduction teams, including annual goal setting, performance reviews, development, and talent management. Ensure products (commercial and NPI/CTS) are manufactured and released in line with marketing authorisation, GMP, and company quality systems. Lead batch review and release, documentation, checks, and test completion. Oversee validation of manufacturing and testing processes and accurate record keeping. Provide quality governance on deviations, planned changes, and exception reporting with proper authorisations and regulatory notifications. Support NPI activities: change plan review, validation, documentation approval, and release of CTS batches Execute regulatory requests and submissions, engage directly with regulatory agencies (FDA, HPRA). Chair Change Review Boards, approve changes, oversee completion of QA tasks. Conduct internal/external audits and participate in regulatory/customer inspections. Manage complaint investigations, coordinate product recalls, and address quality defects. Ensure compliance with FDA CFR Parts 210/211/Q7, EU GMPs (ICH Q7, Volume 4), and QA Policies. Review and approve Product Quality Reviews (PQRs) and track finished product data. Provide QP oversight for SAP, LIMS setup changes, and manage site quality metrics. Act as Designee for the Quality Director when required. Lead department/site goals, provide technical leadership/guidance on QP/regulatory matters, and present technical data for decision-making. What you need to apply: MSc in Industrial Pharmaceutical Science (or a comparable course recognized for QP status per Article 49 of Directive 2001/83/EC). Minimum 10 years' experience in the healthcare/pharma sector within FDA/EMA approved environments. Demonstrated experience leading teams, with 7+ years in leadership roles Demonstrated attention to detail, strong problem-solving and innovative thinking abilities. Results-driven mindset with proven prioritization skills and commitment to quality. High integrity, strong work ethic, excellent verbal/written communication, and interpersonal skills. Skills: Regalutory Quality Assurance Quality Management GMP Benefits: Medical Aid / Health Care Parking Pension Fund Performance Bonus Annual Bonus / 13th Cheque TPBN1_IJ
Team Horizon is seeking a API Engineering Manager for a leading pharmaceutical company in Sligo. This position reports to the Operations Engineering Manager and is responsible for leading and managing a team comprising of engineers, technicians, and apprentices. The Engineering Manager support our API (Active Pharmaceutical Ingredients) business unit. Your role will involve team development, budget management, liaising with production and ensuring compliance with policies related to Personnel, Quality, Engineering, Safety and Finance. Why you should apply: This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses. There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve peoples lives. Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally. What you will be doing: This is a varied position which requires cross-functional collaboration with contract maintenance providers, production, technical operations, quality and other personnel to ensure equipment performance is maximized. Your role will involve working on a variety of projects ranging from continuous improvement to new product introductions. Establish in conjunction with the Operations Engineering Manager the department goals, schedules and timetables for activities. Assist with the management and support of manufacturing equipment development. Support the API Engineering Team in ensuring that manufacturing equipment is maintained to meet the required legal, divisional and corporate standards. Prepare appropriate CAPA plans and implement timelines. Undertake specific investigations, and equipment monitoring, with a view to improve manufacturing performance e.g., reducing plant downtime and maximizing Plant output and yield. Implementation of equipment/process upgrade in an environment of continuous improvement. Develop monthly engineering metrics and provide management reports in a timely manner. Ensure relevant budgets are within target and prepare capital expenditure requests for plant as required. Ensure successful external, Division and Corporate audits. Ensure safety standards are met, and safe working practices are adhered to. Manage internal and external plant projects as needed. Supervise and manage relationships with external contractors. Attend relevant meetings and drive actions to closure. Any other duties as assigned. What you need to apply: Degree (Level 7 or above) in engineering or scientific area (Chemistry) Minimum of 6 years pharmaceutical industry with a minimum of 2 years experience as an Engineering Supervisor. Previous experience in an active pharmaceutical manufacturing facility, particularly within the Engineering Department, is required. Experience with glass lined vessels, reactors, pumps, heat exchangers, ATEX, solvent handling. High level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures. Strong problem-solving skills with the ability to make prompt decisions on engineering related issues Skills: Engineering Engineering Management TLNT1_IJ
Team Horizon is seeking a API Engineering Manager for a leading pharmaceutical company in Sligo. This position reports to the Operations Engineering Manager and is responsible for leading and managing a team comprising of engineers, technicians, and apprentices. The Engineering Manager support our API (Active Pharmaceutical Ingredients) business unit. Your role will involve team development, budget management, liaising with production and ensuring compliance with policies related to Personnel, Quality, Engineering, Safety and Finance. Why you should apply: This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses. There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve peoples lives. Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally. What you will be doing: This is a varied position which requires cross-functional collaboration with contract maintenance providers, production, technical operations, quality and other personnel to ensure equipment performance is maximized. Your role will involve working on a variety of projects ranging from continuous improvement to new product introductions. Establish in conjunction with the Operations Engineering Manager the department goals, schedules and timetables for activities. Assist with the management and support of manufacturing equipment development. Support the API Engineering Team in ensuring that manufacturing equipment is maintained to meet the required legal, divisional and corporate standards. Prepare appropriate CAPA plans and implement timelines. Undertake specific investigations, and equipment monitoring, with a view to improve manufacturing performance e.g., reducing plant downtime and maximizing Plant output and yield. Implementation of equipment/process upgrade in an environment of continuous improvement. Develop monthly engineering metrics and provide management reports in a timely manner. Ensure relevant budgets are within target and prepare capital expenditure requests for plant as required. Ensure successful external, Division and Corporate audits. Ensure safety standards are met, and safe working practices are adhered to. Manage internal and external plant projects as needed. Supervise and manage relationships with external contractors. Attend relevant meetings and drive actions to closure. Any other duties as assigned. What you need to apply: Degree (Level 7 or above) in engineering or scientific area (Chemistry) Minimum of 6 years pharmaceutical industry with a minimum of 2 years experience as an Engineering Supervisor. Previous experience in an active pharmaceutical manufacturing facility, particularly within the Engineering Department, is required. Experience with glass lined vessels, reactors, pumps, heat exchangers, ATEX, solvent handling. High level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures. Strong problem-solving skills with the ability to make prompt decisions on engineering related issues Skills: Engineering Engineering Management TPBN1_IJ
Team Horizon is seeking a Quantity Surveyor Advisor in Dublin to provide expertise for capital projects. Responsibilities include planning, managing compliance with procurement regulations, and delivering projects within budget. Applicants should have a Level 8 QQI award in Quantity Surveying, at least 7 years of relevant experience, and be eligible for professional registration. The role involves collaboration with design teams and adherence to health and safety standards, offering the chance to work in a dynamic environment. #J-18808-Ljbffr
Quantity Surveyor Advisor Team Horizon is seeking a Quantity Surveyor Advisor for a client in Dublin. The purpose of this role is to provide professional advice supporting the preparation, management, and delivery of the health capital programme. They will also provide professional advice on all aspects of procurement, contract and commercial related issues which are related to the delivery of capital projects. Why you should apply: You will join an innovative team, working among a diverse group of visionaries, thinkers and doers, working on developing pioneering solutions that lead to shared success. You enjoy working in a culture of learning and collaboration and making a positive impact. What you will be doing: Assist with the delivery of the Capital plan for the area in compliance with Capital Approval Protocols, Public Procurement requirements and the financial Regulations. Preparation of Capital submissions in accordance with Capital Approval protocols and Infrastructure Guideline requirements. Provide support and advice in strategic planning, briefing, construction, equipping and related matters. Assist with the application of the Infrastructure Guidelines and the various requirements as set out in Guidelines at each of the Project Lifecycle stages as defined in the Infrastructure Guidelines to ensure value for money, the evaluation, planning and management of public investment projects. Provide all relevant procurement, contractual and commercial advice required to deliver the various capital projects being delivered within the area. Developing action plans for the timely and efficient completion of contracts. Co‑ordinating the tender and control stages of projects, having close liaison with design teams, site supervisory staff and hospital personnel. Managing the necessary and appropriate consultation processes and meetings necessary to satisfactory completion of the project. Managing the necessary and appropriate consultation processes and meetings necessary to satisfactory completion of the project. Complying with all regulatory and statutory requirements including permission, licences, certificates, and approvals. Ensure all works are carried out in compliance with Health and Safety regulations. Supervising staff and contractors in the implementation of agreed programmes. Assist in the management of projects and helping to quickly resolve such issues as may be for resolution and agreement. Managing the processing, certification and controlling expenditure on each assigned project. This is to include presentations to the Principal Quantity Surveying Adviser and the local Capital & Estates teams as required, of information and current estimates of total costs, running statements of financial commitment and forecasts of expenditure. Defining requirements for design services, buildings, and equipment. Procurement and selection of Design Teams, other professional services, and contractors for Capital Projects, arranging and managing the procurement processes. Obtaining approval to proposals as necessary in accordance with protocols and regulations in a timely manner. Developing proposals with selected design teams and contractors. Health estate planning, option studies, briefing, design development and project management with a view to optimising value related to best outcomes. What you need to apply: Hold a Level 8 (or higher) Quality & Qualifications Ireland (QQI) major academic award in Quantity Surveying accredited by the relevant Professional Institute (Society of Chartered Surveyors in Ireland, Royal Institution of Chartered Surveyors). Be registered as a Quantity Surveyor or be eligible for registration as a Quantity Surveyor under the Building Control Act 2007. Have a full membership of or be eligible for membership of a relevant professional association. Have had at least 7 years’ satisfactory & relevant experience fulfilling the role of a Quantity Surveyor within either a contractor organisation or a private consultancy business. Candidates must possess the requisite knowledge and ability (including a high standard of suitability and of administrative capacity) for the proper discharge of the duties of the office. Membership of the relevant professional association: Society of Chartered Surveyors in Ireland / Royal Institution of Chartered Surveyors. Candidates should have full, professional membership i.e. be a chartered member of the Society of Chartered Surveyors in Ireland and/or Royal Institute Chartered Surveyors (Quantity Surveying). Good Knowledge and Experience of the design and construction and maintenance requirements of buildings and building services. #J-18808-Ljbffr
MES Engineer Team Horizon is seeking a MES Engineer for a pharmaceutical client in Sligo. This person will be supporting multiple projects within MES across Medical Device and Biologics divisions. Why you should apply: This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses. There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives. Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally. What you will be doing: Support SAP and MES strategy. Continuously review and manage business risk associated with POMSnet system and recipes. Continuously review and ensure all business processes, including SOPs, required to implement and manage SAP and POMSnet system changes and POMSnet recipe changes comply with current Safety, Quality and Information Technology policies. Continuously review and ensure all documented policies, procedures and training plans required to implement and manage SAP and POMSnet system changes and POMSnet recipe changes comply with current Security, Quality and Information Technology requirements. Ensure the timely and compliant qualification of POMSnet recipes and upgrades aligned with business objectives. Support SAP business system as local key user (LKU) for POMSnet and material queries. Communicate project status by preparing standard status reports, and by participating in departmental and customer project status update meetings. Resolve project/system/ recipe issues by working with team members, project customers, and others as appropriate. Responsible for systems compliance with quality related SOPs. Promote a culture of perfect performance and right first time within their team. Required to front audits by HPRA/FDA or Customers on SAP and MES. Participate in MES knowledge exchange with MES and other sites. Participate in MES Technical Review Board (TRB) Meetings, and manage issues, workarounds and fixes identified. Participate in projects from initiation to ensure MES system or hardware requirements are understood and taken into consideration. What you need to apply: Demonstrated working knowledge of Manufacturing Execution Systems is required for this role. Relevant science/engineering or IT discipline OR Degree in Relevant science/engineering or IT discipline. A minimum of three years’ experience in an FDA/HPRA regulated industry. A strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role. A good knowledge of the POMSnet or other MES system is required for this role. Experience of operating in a team environment with active participation in proactive improvement programs is required. #J-18808-Ljbffr
Team Horizon is seeking a MES Engineer for a pharmaceutical client in Sligo. The role involves supporting SAP and MES strategy, assuring compliance with quality related SOPs, and actively engaging in project updates while managing business risks associated with the POMSnet system. Candidates need a degree in a relevant discipline, three years of experience in an FDA/HPRA regulated environment, and knowledge of manufacturing execution systems. Competitive opportunity to contribute to a world-class manufacturing operation. #J-18808-Ljbffr
